Select Committee on European Scrutiny First Report


COM(00) 435

Draft Council Regulation amending Annex II of Council Regulation
(EEC) No. 2377/90 laying down a Community procedure for the
establishment of maximum residue levels of veterinary products in
foodstuffs of animal origin.

Legal base: Article 37 EC; for voting procedure, see paragraph 6.4 of previous Committee Report
Department: Agriculture, Fisheries and Food
Basis of consideration: Minister's letter of 29 November 2000
Previous Committee Report: HC 23-xxvii (1999-2000), paragraph 6 (25 October 2000)
Considered by the Council: 28 September 2000
Committee's assessment: Legally and politically important
Committee's decision: Cleared


  6.1  Because of the possible risks to human health, and in order to avoid the fragmentation of the market as a result of different actions being taken by Member States, Council Regulation (EEC) No. 2377/90[21] establishes a Community procedure for establishing maximum residue levels (MRLs) of veterinary medicinal products in foodstuffs of animal origin. The Regulation also provides for substances subject to it to be classified in one of four Annexes — Annex I covers those for which MRLs have been fixed following an examination of the risk they pose to human health; Annex II those for which MRLs are judged to be unnecessary; Annex III those believed to be safe, and for which provisional MRLs have been fixed in the absence of definitive scientific data; and Annex IV those for which no MRLs can be fixed because residues, at whatever limit, constitute a health hazard.

  6.2  Bovine somatotropin (BST) is a hormone produced naturally by all cows, and is necessary to stimulate milk production. Since the early 1980s, it has proved possible to manufacture it, the manufactured form being known as recombinant bovine somatotropin (rBST). However, because the various animal welfare and human health effects of using it are not sufficiently clear, there is now a permanent ban on its marketing and administration.

  6.3  The current proposal arose because, notwithstanding the ban on rBST, its manufacturers had maintained their applications for an MRL to be set for the product, and the Court of First Instance ruled that a marketing ban does not justify a refusal to grant an MRL. We understand that this decision is now subject to appeal before the European Court of Justice. In the meantime, it led the Commission to put to the Standing Committee on Veterinary Medicinal Products in February 2000 a proposal that rBST should be added to the list of products in Annex II to Council Regulation No. 2377/90. However, since that Committee was unable to approve the proposal, it was necessary to refer it to the Council, which on 28 September 2000 endorsed the view that, on the basis of the precautionary principle, this was an "inappropriate" time to fix an MRL for rBST.

  6.4  In the conclusion to our Report of 25 October 2000, we said that, although we could understand the Council's reluctance to agree to a proposal which would have placed this substance in a category for which no MRL was judged to be necessary, there were two points on which we would like the Government to comment further.

  6.5  First, it appeared that one consequence of the Council's decision is that rBST will remain outside the scope of any of the Annexes to Council Regulation 2377/90, and would thus have no MRL applied to it. In that case, it was not clear to us what would then be the difference in practice between that situation and the one which would have arisen had rBST been included in Annex II.

  6.6  Secondly, to the extent the Council's decision not to set an MRL for rBST runs counter to the ruling of the Court of First Instance, we suggested that it presumably remained open for the manufacturers who had requested this to challenge that decision.

Minister's letter of 29 November 2000

  6.7  In her letter of 29 November 2000, the Minister of State (Lords) at the Ministry of Agriculture, Fisheries and Food (Baroness Hayman) says that it is true that the Council's rejection of the proposal achieved no practical effect, but that to have accepted it would have been to accept that there are no human safety concerns relating to rBST. She adds that this is not the case, in that, although the Veterinary Products Committee has advised that the risk from drinking milk from rBST treated cows is likely to be extremely small, the possibility of an increased risk of colonic cancer cannot be ruled out without further studies. Consequently, acting on precautionary grounds, the Government was unable to accept the proposal for the entry of rBST into Annex II of Council Regulation No. 2377/90.

  6.8  On our second point, the Minister agrees that the possibility of further litigation, arising from a decision by the companies concerned to challenge the Council's decision, cannot be ruled out.


  6.9  We are grateful to the Minister for these comments, and, whilst it is arguable that the small human health risk involved might have justified the Commission proposing a maximum residue level (MRL) under Annex I of Council Regulation (EEC) No. 2377/90, we accept the logic of the Government's response to the proposal which was actually put forward. We are, therefore, now clearing this document.

21   OJ No. L 224, 18.8.90, p.1. Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2000
Prepared 29 December 2000